A Study To Evaluate The Safety, Tolerability And Pk Of Pazopanib Eye Drops In Healthy Adult And Elderly Subjects.
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|ClinicalTrials.gov Identifier: NCT00463320|
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : March 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Macular Degeneration Age-related Macular Degeneration||Drug: Pazopanib eye drops and Allergen Refresh Plus eye drops||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Placebo-controlled, Randomized, Dose Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Ocular Doses of Pazopanib in Healthy Adult and Elderly Subjects.|
|Study Start Date :||March 2007|
|Actual Study Completion Date :||August 2007|
- Ocular safety by observation and eye exams. [ Time Frame: at baseline, each dosing day and follow-up ]
- General safety by PE, VS, cardiac monitoring, clinical laboratory tests and adverse events reporting . [ Time Frame: day-1,5,10,14 ]
- Pazopanib exposure by AUC and Cmax . [ Time Frame: day 1,14 ]
- Pazopanib exposure measured by secondary pharmacokinetic parameters at day 1 and 14.
- Safety endpoints include complete ophthalmic examination, vital signs (heart rate and blood pressure), cardiac monitoring (electrocardiogram), clinical laboratory tests, clinical monitoring and adverse event reporting.
- Change in visual acuity (number of letters read on standardized ETDRS charts).
- Change in retinal morphology (i.e. CNV, intraretinal cysts, intraretinal fluid, subretinal fluid, and retinal pigment epithelial detachment) as determined by OCT.
- Change in neovascular size, lesion size and characteristics (fibrosis, atrophy, blood) as measured by fluorescein angiography and fundus photography.
- Cmax, tmax, and AUC(0-24) of plasma pazopanib, if data are sufficient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463320
|United States, North Dakota|
|GSK Investigational Site|
|Fargo, North Dakota, United States, 58104|
|United States, Texas|
|GSK Investigational Site|
|Austin, Texas, United States, 78744|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|